New lidocaine formulation for managing postoperative pain
A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery
This study is testing a new long-lasting lidocaine treatment to see if it can help people manage pain better after pelvic and perineal surgeries compared to standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT05193227 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new sustained release lidocaine formulation, ST-01, for its effectiveness in controlling postoperative pain following various pelvic and perineal surgeries. Participants will receive either the new formulation or standard care after surgery, and their pain levels and opioid consumption will be monitored over 30 days. The goal is to determine if ST-01 can provide longer-lasting pain relief compared to traditional lidocaine injections. The study will involve up to 120 subjects who will be randomized to receive either treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who are scheduled for surgery involving a pelvic incision.
Not a fit: Patients with chronic pain conditions or known allergies to lidocaine may not benefit from this study.
Why it matters
Potential benefit: If successful, this new formulation could significantly reduce postoperative pain and decrease reliance on opioid medications.
How similar studies have performed: While the approach of sustained release lidocaine is novel, similar studies have shown promise in improving pain management post-surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any sex, aged ≥ 19 years * Indication to undergo an operation with a planned pelvic incision * Able and willing to provide informed consent * Stated willingness to comply with all study procedures and availability for the duration of the study * If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study Exclusion Criteria: * History of chronic pain conditions associated with the use of opioids or steroids * Known allergic reactions to any components of the investigational product * Active infection involving the surgical site * Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication) * Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant) * Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period * Has any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reason
Where this trial is running
Vancouver, British Columbia and 1 other locations
- Vancouver Prostate Centre — Vancouver, British Columbia, Canada (Recruiting)
- St. Pauls Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Lesley Parker
- Email: lparker@sustainedtx.com
- Phone: 604 875 5594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.